Division of Hepatology and Complex GI, Physicians Foundation California Pacific Medical Center, San Francisco, CA 94115-1932, USA.
J Viral Hepat. 2010 Jan;17(1):16-22. doi: 10.1111/j.1365-2893.2009.01146.x. Epub 2009 Jul 19.
This retrospective analysis was conducted to describe the characteristics of nucleoside-naïve hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B, who achieved hepatitis B surface antigen (HBsAg) loss during entecavir or lamivudine therapy. HBeAg-positive adults with chronic hepatitis B, elevated serum alanine aminotransferase, and compensated liver disease were randomized to double-blind treatment for up to 96 weeks with entecavir 0.5 mg/day or lamivudine 100 mg/day. HBsAg and hepatitis B virus (HBV) DNA were measured at regular intervals during and off-treatment follow-up. Through a maximum duration of 96 weeks on-treatment and 24 weeks off-treatment, HBsAg loss was confirmed in 18/354 (5.1%) patients treated with entecavir and 10/355 (2.8%) patients treated with lamivudine. Among the 28 patients with confirmed HBsAg loss, 27 (96%) achieved HBV DNA <300 copies/mL, and 27 (96%) achieved confirmed HBeAg loss. All entecavir recipients with HBsAg loss had HBV DNA <300 copies/mL. Caucasian patients, and those infected with HBV genotype A or D, were significantly more likely to lose HBsAg. This retrospective analysis of data from a randomized, global phase three trial shows that confirmed loss of HBsAg occurred in 5% of nucleoside-naïve HBeAg-positive patients treated with entecavir, and that HBsAg loss is associated with sustained off-treatment suppression of HBV DNA.
本回顾性分析旨在描述恩替卡韦或拉米夫定治疗期间实现乙肝表面抗原（HBsAg）丢失的核苷初治 HBeAg 阳性慢性乙型肝炎患者的特征。将 HBeAg 阳性、慢性乙型肝炎、血清丙氨酸氨基转移酶升高和代偿性肝病的成年患者随机分为两组，接受恩替卡韦 0.5mg/天或拉米夫定 100mg/天的双盲治疗，最长疗程为 96 周。在治疗期间和治疗后随访期间定期检测 HBsAg 和乙型肝炎病毒（HBV）DNA。通过最长 96 周的治疗和 24 周的停药随访，18/354（5.1%）例接受恩替卡韦治疗的患者和 10/355（2.8%）例接受拉米夫定治疗的患者确认 HBsAg 丢失。在 28 例确认 HBsAg 丢失的患者中，27 例（96%）患者 HBV DNA<300 拷贝/ml，27 例（96%）患者确认 HBeAg 丢失。所有 HBsAg 丢失的恩替卡韦治疗患者的 HBV DNA<300 拷贝/ml。白种人患者以及感染 HBV 基因型 A 或 D 的患者更有可能丢失 HBsAg。这项对一项随机、全球性三期临床试验数据的回顾性分析表明，5%的核苷初治 HBeAg 阳性慢性乙型肝炎患者接受恩替卡韦治疗后可确认 HBsAg 丢失，HBsAg 丢失与治疗结束后 HBV DNA 的持续抑制有关。
